An interventional study of Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks) and Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin) in Brucellosis and Osteoarticular Brucellosis, sponsored by The First Affiliated Hospital of Shihezi University. Not yet recruiting. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by The First Affiliated Hospital of Shihezi University · Not applicable, Interventional, and Treatment
Brucellosis is a globally distributed zoonosis with persistent clinical management challenges. The World Health Organization (WHO)-recommended doxycycline-rifampin (DOX-RIF) dual regimen may drive rifampin-associated antimicrobial resistance in brucellosis-endemic regions. Patients with osteoarticular brucellosis, the most common focal complication of brucellosis, often require long-term intravenous ceftriaxone triple therapy. This parenteral regimen leads to poor treatment adherence, frequent hospital visits and heavy outpatient burdens. Fluoroquinolones (levofloxacin [LVX], moxifloxacin [MXF]) exert excellent anti-Brucella activity and superior bone-joint penetration. However, high-quality multicenter prospective data comparing rifampin-sparing LVX-DOX / MXF-DOX regimens against the standard RIF-DOX regimen remain scarce. Existing comparative studies are limited to small single-center retrospective cohorts or trials combining rifampin with fluoroquinolones rather than rifampin-free all-oral triple regimens.
This multicenter, randomized, open-label, non-inferiority trial intends to evaluate the efficacy and safety of two all-oral fluoroquinolone-based triple regimens compared with standard doxycycline-rifampin therapy for patients with imaging-confirmed osteoarticular brucellosis. Osteoarticular brucellosis is the most frequent focal complication of brucellosis. Rifampin resistance and poor adherence to long-term intravenous treatment are major clinical challenges. Fluoroquinolones have good bone-joint penetration and anti-Brucella activity. The primary outcome is clinical cure rate. Secondary outcomes include relapse, adverse reactions and inflammatory response changes. This study is expected to support optimized oral therapeutic options for osteoarticular brucellosis in endemic areas.
53 studies on the registry are indexed under Brucellosis; 20 are open to participants now.
This study's planned enrollment of 150 is above the median of 52 across 25 interventional studies indexed under Brucellosis.
Browse Brucellosis studies →The First Affiliated Hospital of Shihezi University is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Enrolled brucellosis patients with osteoarthritic complications, treated with triple therapy combining oral doxycycline, rifampicin and 4-week intravenous ceftriaxone.
Drug: Doxycycline + Rifampicin + Ceftriaxone (intravenous therapy for 4 weeks)
Enrolled brucellosis patients with osteoarticular complications, treated with an 8-week oral triple regimen: doxycycline + rifampicin + levofloxacin.
Drug: Triple oral regimen (Doxycycline + Rifampicin + Levofloxacin)
Enrolled patients with uncomplicated brucellosis, treated with an 8-week oral dual regimen of doxycycline combined with moxifloxacin.
Drug: Triple oral regimen (Doxycycline + Rifampicin + Moxifloxacin)
Drug pages: Doxycycline · Rifampin · Ceftriaxone
Triple combined regimen for moderate-severe osteoarticular brucellosis. Patients take oral doxycycline and rifampicin continuously, plus 4 weeks of intravenous ceftriaxone infusion. The scheme targets complicated joint and bone lesions to strengthen antibacterial efficacy for severe cases.
Full-course oral triple regimen for brucellosis treatment. Patients continuously take oral doxycycline, rifampicin and levofloxacin for 8 weeks. This regimen boosts antibacterial potency against bone-joint brucellosis lesions and lowers rifampicin resistance risks compared with dual-drug schemes.
Full-course oral triple regimen for brucellosis therapy. Patients take oral doxycycline, rifampicin and moxifloxacin daily for an 8-week treatment cycle. Moxifloxacin delivers outstanding bone-joint tissue penetration, enhancing curative effects for osteoarticular brucellosis and reducing rifampicin resistance risks relative to dual-drug regimens.
Clinical cure rate at Week 12 (end of treatment)
Composite clinical cure defined as resolution of systemic symptoms, ≥50 % reduction in visual analog scale (VAS) joint-pain score, and improvement of inflammatory markers at the end of 12-week treatment. Microbiological cure is reported as an exploratory supportive endpoint.
Time frame: 12 weeks after randomization (completion of 12-week treatment)
Recurrence rate at 24 weeks post-treatment
Proportion of participants with confirmed osteoarticular brucellosis recurrence 24 weeks after treatment cessation.
Time frame: 24 weeks after completion of 12-week therapy
Recurrence rate at 48 weeks post-treatment
Proportion of participants with confirmed osteoarticular brucellosis recurrence 48 weeks after treatment cessation.
Time frame: 48 weeks after completion of 12-week therapy
Time to achieve ≥50 % reduction in VAS joint-pain score
1\. Time (in weeks) from randomization until achieving at least 50 % reduction from baseline in VAS joint-pain score.
Time frame: Throughout the 12-week treatment period
Radiologic improvement rate at 24 and 48 weeks post-treatment
Proportion of participants with radiologic improvement on CT or MRI imaging at 24-week and 48-week follow-up.
Time frame: 24 weeks and 48 weeks after completion of 12-week therapy
Change in SF-36 health-related quality-of-life scores
Change from baseline in 36-Item Short Form Health Survey (SF-36) quality-of-life scores measured at Week 12, Week 24, and Week 48.
Time frame: Baseline, Week 12, Week 24, Week 48
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores
Change from baseline in BASDAI functional scores assessed at Week 12, Week 24, and Week 48.
Time frame: Baseline, Week 12, Week 24, Week 48
Treatment completion rate (medication adherence >90 %)
Proportion of participants with medication adherence greater than 90 % during the 12-week treatment course.
Time frame: 12-week treatment period
Incidence of treatment-related adverse events
Treatment-related adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From treatment initiation through Week 48
No study locations are listed for this record.
Plan to share: No — The individual participant data will not be shared due to restrictions related to participant privacy and local institutional regulations
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Shihezi University